Kit comprising a supporting device for a transparent article and a polarimeter

ABSTRACT

The present invention relates to a kit comprising a supporting device for maintaining a transparent article having a longitudinal axis A, a proximal end and a distal end, said supporting device including a proximal holder including a port intended to receive the proximal end of said article, and a distal holder including a receiving part intended to receive the distal end of said article, said port and said receiving part being aligned on the same longitudinal axis B, said supporting device further comprising compression means for putting said article under longitudinal compression directed towards a center of said article, when said article is mounted on said supporting device with its longitudinal axis A aligned on said longitudinal axis B, and a polarimeter. The invention also pertains to a method for measuring the stress inside an article made of transparent material.

The present invention relates to a kit comprising a supporting devicefor maintaining under compression in a substantially determined positionan article made of a transparent material, and a polarimeter formeasuring the stress in the material of the article once said article ismounted on said supporting device. The article may be a medical devicelike syringe bodies or ampoules. The invention further relates to amethod for putting under compression an article made of a transparentmaterial, such as syringe bodies and/or cartridges and/or ampoulesand/or vials, using such a supporting device and a polarimeter, in orderfor example to perform further analysis of said article.

A lot of medical devices are made of transparent material such as glass,polycarbonate, polyolefin like polyethylene, polypropylene, CCP (CristalClear polymer) or polystyrene. For such uses as those of the medicalfield, these medical devices must be totally safe and must not breakwhen handled. Moreover, the medical devices made in brittle materialsuch as glass or polycarbonate usually show complex shapes such astubular shapes: this is the case in particular of syringe bodies,cartridges, ampoules or vials used for storing and/or administeringmedicine to a patient.

Nevertheless, although it is known to measure the stress in a classicalplanar piece of transparent material such as flat glass for example,there still lacks a reproducible method for putting under compression anarticle and measuring the amount of stress inside such an article madeof such a transparent material, in particular when the article has acomplex shape.

Indeed, such a method and means for completing such a method in areproducible way would be of great interest. Actually, it happens that apercentage of the just manufactured syringe bodies and/or ampoules whichare provided to the pharmaceutical companies in order to be filled inwith the adequate medicine may break at the time they are handled.

There is therefore a need for a reproducible method for maintaining incompression, and optionally further measuring the resistance of, medicalarticles made of brittle transparent material such as glass, polyolefinor polycarbonate, and showing relatively complex shapes, such as tubularshapes.

The present invention aims at providing means, and in particular a kitcomprising a specific supporting device, able to maintain, preferablyunder compression, and rotate the article to be measured, for completingsuch a reproducible method.

A first aspect of the present invention is a kit comprising a supportingdevice for maintaining under longitudinal compression an article made oftransparent material and having a longitudinal axis A, a proximal endand a distal end, said supporting device including a proximal holderincluding a port intended to receive the proximal end of said article,and a distal holder including a receiving part intended to receive thedistal end of said article, said port and said receiving part beingaligned on the same longitudinal axis B, wherein said supporting devicefurther comprises compression means for putting said article underlongitudinal compression directed towards a center of said article, whensaid article is mounted on said supporting device with its longitudinalaxis A aligned on said longitudinal axis B, said kit further including apolarimeter for measuring the stress in the material of the article whensaid article is mounted on said supporting device.

As will appear from the description below, “under longitudinalcompression” means in the present application that, once the article ismounted on the supporting device of the kit of the invention, it issubmitted to a minimum compressive force, exerted along the longitudinalaxis A of said article and in the direction of the center of saidarticle, so that said article does not detach or fall off from saidsupporting device under the effect of gravity, regardless of thedirection of said longitudinal axis A and B, which are aligned on eachother, with respect to the environing space: in other words, once thearticle is mounted on said supporting device, the article is submittedto said longitudinal compression regardless of the fact that thelongitudinal axis B is vertical (supporting device in a verticalposition), horizontal (supporting device in a horizontal position) orinclined (supporting device in any inclined position). In other words,the longitudinal compressive force applied to said article correspondsto a force above 0 Newton. As it will also appear from the description,this longitudinal compressive force may vary in a range from above 0 toless than 1000 Newton depending on which measurements need to beperformed on said article. For example, the longitudinal compressiveforce is the force applied at least one end, for example at both ends,of the article, in the direction of the center of the article along itslongitudinal axis, once the article is mounted on the supporting device.

In the present application, the distal end of an article is to beunderstood as meaning the end furthest from the user's hand and theproximal end is to be understood as meaning the end closest to theuser's hand when the article is in use. Likewise, in this application,the “distal direction” is to be understood as meaning the direction ofinjection, and the “proximal direction” is to be understood as meaningthe opposite direction to the direction of injection. By similarity,although the supporting device of the kit of the invention is notintended to be used for an injection operation, the term “proximal”applied to the supporting device of the kit of the invention, is used inreference to the part of the supporting device receiving the proximalend of said article, and the term “distal” applied to the supportingdevice of the kit of the invention, is used in reference to the part ofthe supporting device receiving the distal end of said article.

Thanks to the supporting device of the kit of the invention, and as willappear from the description below, the medical article, and inparticular the tubular barrel of a syringe body or of a cartridge or ofan ampoule or of a vial, is maintained under longitudinal compression ina determined position, for example horizontal, vertical or inclined, bymeans of its proximal and distal ends only contacting said supportingdevice. As a result, the space surrounding the article to be measured,and in particular the space surrounding the part of the article to bemeasured, is totally free of any disturbing element in the threedirections. For example, the part of the article to be measured need notbe in contact with or bear on an additional support, which would belikely to distort potential measures to be made on said article. Inaddition, in such determined position, the article or the tubular barrelmay be rotated, again by means of its proximal and distal ends onlycontacting said supporting device. For example, if measurements are tobe performed on the article with a polarimeter, there is no need of anyadditional supporting element that would interfere with the light sentby the polarimeter in the direction of the central part of the articleor the tubular barrel. In particular, thanks to the structure andarrangement of the supporting device of the kit of the invention, thespace between the proximal holder and the distal holder is free from anyadditional element. As a consequence, it is possible to use apolarimeter, and to focus the light of said polarimeter on the articleor on the part of the article to be measured without any intermediateelement located between the polarimeter and the article or such part ofthe article to be measured. The light of the polarimeter encounterstherefore no obstacle before reaching the part of the article to bemeasured, for example the tubular barrel of a syringe body.

In an embodiment of the invention, at least one of said port andreceiving part is rotatable around said longitudinal axis B.

In such an embodiment, because at least the port or the receiving partof the supporting device of the kit of the invention is rotatable, thearticle to be measured, once mounted on the supporting device of the kitof the invention, may be rotated. In case a polarimeter is used, thisallows measuring the value of stress inside the article, for exampleinside the tubular barrel, or inside the distal tip, of a syringe body,after several rotations of the article or of the tubular barrel or ofthe distal tip to be measured. In case the article to be measured has acomplex shape such as a tubular shape, for example a tubular barrel,this allows obtaining measures at different points of the circumferenceof the article or of the barrel, all along said circumference, andtherefore to eventually obtain reproducible average values of the stressinside the article or barrel.

In an embodiment of the invention, said port and said receiving part areboth rotatable around said longitudinal axis B. Such an embodimentallows a safer and smoother rotation of the article to be measured. Therotation may be completed manually by the user, or automatically bymeans of a motor.

In an embodiment of the invention, said port is fixed in translationwith respect to said proximal holder along the direction of saidlongitudinal axis B. For example, when said port is also rotatable, suchan embodiment allows to provide said proximal holder with a motor so asto render the rotation of said port automatic: an automatic rotationallows a quicker, safer, more repeatable and more reproducible rotation.In an embodiment of the invention, said port being rotatable, saidproximal holder is further provided with a motor so as to render saidrotation of said port automatic.

In an embodiment of the invention, said receiving part is movable intranslation with respect to said distal holder along the direction ofsaid longitudinal axis B. Such an embodiment allows adjusting the lengthof the space located between the port and the receiving part, so thatarticles of various lengths may be mounted on the supporting device.Such an embodiment also allows adjusting the longitudinal compressiveforce to be applied on the article once said article is mounted on saidsupporting device, by increasing or decreasing the distance between theport and the receiving part.

In an embodiment of the invention, the compression means comprisesbiasing means tending to urge one of said port and said receiving parttoward the other one of said port and receiving part: for example, saiddistal holder is provided with biasing means tending to urge saidreceiving part in the proximal direction. Said biasing means may forexample be under the form of a helical spring located around alongitudinal shaft bearing either the port or the receiving part. Thepresence of such a biasing means tending for example to urge thereceiving part in the proximal direction allows the receiving part toabut on the distal end of the article to be measured, and contributes toset up the longitudinal compressive force enabling the safe maintainingof the article in the determined position. Such a longitudinalcompressive force should nevertheless preferably not be greater than1000 N so as to avoid that the article breaks once mounted on thesupporting device. For example, in order to warrant that saidlongitudinal compressive force does not interfere with the opticalvision at the time of measuring the stress inside the article with apolarimeter, said longitudinal compressive force is preferably less than20 N.

In an embodiment of the invention, said port is provided with a distalconic part distally tapered. As it will appear later in the description,such an embodiment allows the port to be engaged, in particular withfriction due to the presence of the longitudinal compressive force,inside the proximal end of the tubular barrel of a syringe body, forexample at the level of the flange in the case the syringe body isprovided with a proximal flange. Because the port is engaged withfriction inside the proximal end of the article to be measured, therotation of the port will cause the rotation of the article to bemeasured, such as the syringe body for example.

In another embodiment of the invention, said port is provided with aring, the distal face of which is provided with a central recess. Suchan embodiment may be used in particular with an ampoule, a cartridge ora vial having a proximal end provided with a flat bottom. In such acase, when the ampoule, cartridge or vial is mounted on the supportingdevice of the kit of the invention, the flat bottom of the ampoule,cartridge or vial is engaged in the central recess provided in thedistal face of the ring, preferably by friction, in particular due tothe presence of the longitudinal compressive force. As seen above forthe previous embodiment, because the flat bottom of the proximal end ofthe ampoule, cartridge or vial is engaged with friction inside thecentral recess of the distal face of the ring of the port, the rotationof the port will cause the rotation of the article, ie the ampoule, thecartridge or the vial for example, to be measured.

In an embodiment of the invention, said receiving part is provided witha ring traversed by a central channel aligned on said longitudinal axisB. Such an embodiment allows the distal tip of a syringe body or anampoule for example to be received safely within the receiving part. Inparticular, it is possible to mount a syringe body provided with aneedle on the distal tip, the needle being received within said centralchannel.

For example, the proximal portion of said central channel has the shapeof a cone distally tapered. Such a shape is particularly useful when thearticle to be measured, such as a syringe body or an ampoule, has adistal conic tip.

In alternative embodiments, the receiving part is adapted for receivingthe distal end of a vial, such as a collar for example. In such a case,the receiving part may be provided with a ring, the proximal face ofwhich is provided with a central recess intended to receive said collar.

In alternative embodiments, the receiving part is fixed in translationwith respect to the distal holder and said distal holder is providedwith a motor so as to render the rotation of said receiving partautomatic. In other embodiments also, the port may be movable intranslation with respect to the proximal holder, so as to adjust thelength of the space defined between the port and the receiving part tothe length of the article to be measured, and/or so as to adjust thevalue of the compressive force to be applied on said article.

Also, the port may be urged towards the distal direction by means of abiasing means, in the same manner as described above for the receivingpart.

In embodiments of the present invention, the kit further comprises saidarticle made of a transparent material and having a longitudinal axis A,a proximal end and a distal end.

By “transparent material” is meant according to the present application,a material allowing at least 5% of light transmission in the visible,preferably allowing at least 50% of light transmission in the visible,and more preferably allowing at least 90% of light transmission in thevisible. As an example, glass usually allows at least 90% of lighttransmission in the visible. For example, opalescent materials, whichallow at least 5% of light transmission in the visible, for example atleast 50% of light transmission in the visible, may be used in thepresent invention. Translucent materials, which allow the diffusion of acertain percentage of the light they receive, and which also allow atleast 5% of light transmission in the visible, for example at least 50%of light transmission in the visible, may also be used in the presentinvention. Opalescent materials and translucent materials are thereforecomprised in the term “transparent” according to the presentapplication.

In an embodiment of the kit of the invention, said article has asubstantially tubular shape, such as a syringe body, a cartridge, a vialor an ampoule.

For example, said transparent material is selected from glass,polyolefin, polycarbonate and combinations thereof. In embodiments, thetransparent material is glass.

In an embodiment of the kit of the invention, said article is a syringebody having a tubular barrel provided with a substantially conic distaltip, said supporting device comprising a port provided with a distalconic part distally tapered and a receiving part provided with a ringtraversed by a central channel aligned on said longitudinal axis B, saiddistal conic part being engaged by friction in a proximal end of saidtubular barrel and said conic distal tip being engaged in said centralchannel when said syringe body is mounted on said supporting device. Inparticular, in such an embodiment, when said syringe body is mounted onsaid supporting device, said syringe body is maintained underlongitudinal compression.

In an embodiment of the invention, said syringe body is made of glass.

In an embodiment of the invention, said article being mounted on saidsupporting device, and said transparent material having a refractiveindex RI, said supporting device and article are immersed within aliquid having a refractive index substantially identical to RI. Such anembodiment allows measuring the stress within the thickness of thetransparent material forming the article with a polarimeter: forinstance, in the case of a syringe body having a barrel out of glass,such an embodiment allows to measure the stress within the thickness ofthe barrel wall, using a polarimeter.

The kit of the invention further includes a polarimeter for measuringthe stress inside the article, once said article is mounted on saidsupporting device.

Alternatively or in combination, the kit of the invention may furtherinclude other analysis instruments, like for example microscopes orcameras used in combination with a light source such as UV, visible orLASER light, for measuring other parameters and/or properties of thearticle. As examples of such instruments, one can cite instruments foranalyzing the quality of the homogeneity of the material forming thearticle along a circumference of said article for example or along thelength of the article, or the quality of printings performed on theouter or inner surface of the article, etc. . . . . In embodiments, thearticles to be measured may be provided with an inner coating and/or anouter coating. In such cases, the kit of the invention may also includeanalysis instruments for measuring properties, like thickness,homogeneity, etc., of said coating(s).

Another aspect of the invention is a method for measuring the stressinside an article having a longitudinal axis A, a proximal end and adistal end and made of a transparent material, comprising the steps ofi) mounting said article on a supporting device as described above, byengaging said proximal end of said article into said port and saiddistal end of said article into said receiving part, ii) applying onsaid article a longitudinal compressive force of more than 0 Newton andiii) measuring the stress inside the article with a polarimeter bydirecting the light of said polarimeter towards said article.

In embodiments, the longitudinal compressive force ranges from above 0to less than 1000 N. In embodiments, the compressive force ranges from20 to 1000 N. The longitudinal compressive force may range from 300 to1000N.

For example, the method of the invention may be used for first stressingthe material forming the article and then measuring the stress insidethe article in order to test such material in such a stressingcondition. In such embodiments, the longitudinal compressive force mayrange from 20 to 1000 N, preferably from 300 to 1000 N.

In other embodiments, for example when one wishes to measure the stressinside the article when said article is not submitted to specificstressing conditions, the longitudinal compressive force may range fromabove 0 to 20 N.

For example, the longitudinal compressive force may be adjusted byincreasing or decreasing the distance between the port and the receivingpart of the supporting device of the invention. Alternatively or incombination, the longitudinal compressive force may be adjusted byselecting a specific constant K for the helical spring of the supportingdevice of the kit of the invention as described above.

Preferably, said article has a substantially tubular shape, such as abarrel. Preferably, said article is as described above. Said article maybe chosen among cartridges, syringe bodies, ampoules and vials asdescribed on FIGS. 2 a to 2 d and may be made of transparent materialsuch as glass, polyolefin or polycarbonate.

In an embodiment of the method of the invention, said article having asubstantially tubular shape, such as a barrel, said article is rotatedaround the longitudinal axis B of an angle selected in the range of0-360° and the stress inside the article is measured.

Generally, the window of analysis is adapted to the rotation angle. Thesmaller the window is, the smaller the angle of analysis is, the higherthe number of measurements is, and then, the more precise the resultingmeasurement is.

For example, the article is rotated 6 times of an angle of 30° and thestress inside the article is measured after each rotation. A repeatable,reproducible average value of the stress present inside the article, thebarrel in the case of a syringe body, can therefore be obtained.

Such a method, thanks to the kit of the invention, allows obtainingreproducible measures of the stress inside the article made of thetransparent material, the barrel in the case of a syringe body. Inembodiments, the article being a syringe body comprising a barrel and adistal tip, the stress may be measured inside the barrel and/or insidethe distal tip.

It is therefore possible to set up a limit value above which themeasured article should not be kept for future operations and should bedisposed of, because too likely to break when handled.

The kit and method of the invention will now be further described inreference to the following description and attached drawings in which:

FIG. 1 is a perspective view of the supporting device of the kit of theinvention,

FIG. 2 a is a cross section view of a syringe body that can be assessedwith the measuring method of the invention,

FIG. 2 b is a cross section view of first embodiment of an ampoule thatcan be assessed according to the method of the invention,

FIG. 2 c is a cross section view of a second embodiment of an ampoulethat can be assessed according to the method of the invention,

FIG. 2 d is a cross section view of a vial that can be assessedaccording to the method of the invention,

FIG. 3 is a cross section view of the supporting device of FIG. 1 alonga plane containing the longitudinal axis B,

FIG. 4 is a cross section view of the supporting device of FIG. 3 oncethe syringe body of FIG. 2 a is mounted on said supporting device.

With reference to FIGS. 1 and 3 is shown a supporting device 1 of a kitaccording to the invention, capable of maintaining under longitudinalcompression and rotating an article having a longitudinal axis A, suchas those shown on FIGS. 2 a to 2 d.

On FIG. 2 a, is shown an article having a substantially tubular shapeunder the form of a syringe body 2 comprising a tubular barrel 3 havinga longitudinal axis A, a proximal end 3 a and a distal end 3 b. Theproximal end 3 a of the barrel 3 is provided with an outer flange 4providing bearing surfaces for the user at the time of injection. Thedistal end 3 b of the barrel 3 is provided with a conic distal tip 5providing a passage for the transfer of a medicine contained in thebarrel 3 from the syringe 2 to the site of injection. The conic distaltip 5 is intended to receive a needle (not shown).

The syringe body 2, as well as the barrel 3, of FIG. 2 a are preferablymade out of a transparent material, such as glass, polyolefin orpolycarbonate. Glass and polycarbonate are brittle material which maybreak.

By “transparent material” is meant according to the present application,a material allowing at least 5% of light transmission in the visible,preferably allowing at least 50% of light transmission in the visible,and more preferably allowing at least 90% of light transmission in thevisible. Opalescent and translucent materials are comprised in the term“transparent” as used in the present application.

On FIG. 2 b is shown another embodiment of an article suitable for thesupporting device 1 of the kit of the invention. The article of FIG. 2 bhas a longitudinal axis A and has a substantially tubular shape underthe form of an ampoule 6 intended to contain a product (not shown) to beadministered. Although the two opposite ends of such an ampoule 6 areidentical, for purposes of the present application, it is hereinafterreferred to a proximal end of the ampoule 6, under the form of aproximal tapered tip 6 a, and to a distal end of said ampoule 6, underthe form of a distal tapered tip 6 b, as shown on FIG. 2 b.

The ampoule 6 of FIG. 2 b may be made out of transparent brittlematerial such as glass, polyolefin or polycarbonate.

On FIG. 2 c is shown another embodiment of an article suitable for thesupporting device 1 of the kit of the invention. The article of FIG. 2 chas a longitudinal axis A and has a substantially tubular shape underthe form of an ampoule 7. The ampoule 7 has a proximal end under theform of flat bottom 7 a, and a distal end under the form of a distaltapered tip 7 b.

The ampoule 7 of FIG. 2 c may be made out of transparent brittlematerial such as glass, polyolefin or polycarbonate.

On FIG. 2 d is shown another embodiment of an article suitable for thesupporting device 1 of the kit of the invention. The article of FIG. 2 dhas a longitudinal axis A and has a substantially tubular shape underthe form of a vial 8. The vial 8 has a proximal end under the form offlat bottom 8 a, and a distal end under the form of a collar 8 b.

The vial 8 of FIG. 2 d may be made out of transparent brittle materialsuch as glass, polyolefin or polycarbonate.

Alternatively, the article suitable for the present invention may be acartridge.

With reference to FIGS. 1 and 3, the embodiment of the supporting device1 of the kit of the invention shown is particularly suitable forreceiving a syringe body 2 such as described at FIG. 2 a. The supportingdevice 1 includes a proximal holder 100, intended to receive theproximal end 3 a of the barrel 3 of the syringe body 2 of FIG. 2 a, anda distal holder 200, intended to receive the distal end 3 b of thebarrel 3 of the syringe body 2 of FIG. 2 a.

On the example shown the proximal holder 100 comprises a solid body 10traversed by a shaft 11 extending along the longitudinal axis B of saidsolid body 10. At its proximal end 11 a, the shaft 11 is provided with ahandle 12 allowing the shaft 11 to be rotated manually around thelongitudinal axis B. In an alternative embodiment not shown, the solidbody 10 is provided with a motor allowing the automatic rotation of theshaft 11. In order to facilitate and to better control the rotation ofthe shaft 11, the solid body 10 may include ball bearings 13 locatedbetween the solid body 10 and the shaft 11, as shown on FIG. 3.

The shaft 11 is further provided at its distal end 11 b with a port 14extending beyond said solid body 10 in the distal direction. The port 14is provided with a distal conic part 15 distally tapered, the functionof which will be explained later.

On the example shown, the shaft 11 and therefore the port 14 are fixedin translation with respect to the solid body 10 along the direction ofsaid longitudinal axis B.

On the example shown on FIGS. 1 and 3, the distal holder 200 alsocomprises a solid body 20 traversed by a shaft 21 extending along thelongitudinal axis B of said solid body 20 of said distal holder 200. Theshaft 21 of the distal holder 200 is movable in translation with respectto said solid body 20 along the direction of said longitudinal axis B,in the distal or in the proximal direction. In order to block the shaft21 in translation with respect to said solid body 20 in a determinedposition corresponding for example to the size of the article to bemounted on the supporting device, said shaft 21 is provided with atraversing hole 21 a perpendicular to its longitudinal axis: thetraversing hole 21 a receives a screw 22 able to slide within alongitudinal recess 33 arranged in said solid body 20 as said shaft 21is moved in the distal or proximal direction: when the shaft 21 hasreached the adequate determined position, the screw 22 is tightened soas to come in abutment on the solid body 20, thereby blocking said shaft21 in said determined position. The shaft 21 may be advanced in thedistal direction or withdrawn in the proximal direction in order toadjust to the length of the article to be mounted on the supportingdevice of the kit of the invention, and then blocked in translation asjust described.

In an embodiment not shown, the shaft is not provided with a traversinghole, and the screw is directly tightened on said shaft 21 so as toblock it in translation.

On the embodiment shown on FIGS. 1 and 3, the shaft 21 of the distalholder 200 is provided at its proximal end with a head 23 lodging areceiving part 24 intended to receive the conic distal tip 5 of thesyringe body 2 of FIG. 2 a. The receiving part 24 is provided with aring 25 traversed by a central channel 26 aligned on said longitudinalaxis B. The proximal portion 26 a of the central channel 26 has theshape of a cone distally tapered, the function of which will beexplained later.

As shown on FIG. 3, the central channel 26 of the head 23 may beprolonged by a central hole 27 extending within the shaft 21 on acertain length.

Moreover, ball bearings 28 are provided between the head 23 and thereceiving part 24 allowing the receiving part 24 to rotate with respectto the head 23.

An annular seal 32 is mounted around the ring 25 for securing said ring25 to the head 23. Biasing means, under the form of a helical spring 29located around the shaft 21, are provided, between the solid body 20 andthe head 23. Whatever the relative position of the shaft 21 with respectto the solid body 20, the helical 29 spring is in a stressed state, soas to urge the head 23, and therefore the receiving part 24, in aproximal direction. The inner force of the helical spring 29 contributesto setting up the desired longitudinal compressive force to be appliedto the article to be mounted on the supporting device 1. For instance, aspecific constant K of the helical spring 29 may be selected in order toobtain the desired longitudinal compressive force in function of thesize of the article to be mounted on the supporting device 1. As aresult, the helical spring 29 forms part of compression means forputting the article under longitudinal compression directed towards thecenter of the article, when the article is mounted on the supportingdevice with its longitudinal axis A aligned on the longitudinal axis B.

On the embodiment shown on FIGS. 1 and 3, the supporting device 1 of thekit of the invention is further provided with a sole 30 having an evenbottom face 31 intended to be put on a horizontal plane. Both proximaland distal holders (100, 200) of the supporting device 1 of the kit ofthe invention are permanently fixed to said sole 30 so that theirposition with respect to each other may not vary.

As will appear from description of FIG. 4 below, the article to bemeasured by the supporting device 1 of FIGS. 1 and 3 is maintained underlongitudinal compression in a substantially horizontal position onceinstalled on said supporting device 1. As seen above, the longitudinalcompressive force applied to the article, once said article is mountedon the supporting device is above 0 Newton, so that said article doesnot fall off or detach from the supporting device. Depending on thepurposes for which the article is mounted on the supporting device 1,the longitudinal compressive force may vary from above 0 to 1000 N.

For instance, as will appear below, the user may wish to measure with apolarimeter the properties of the material forming the article when saidmaterial is submitted to a specific stress: in such a case, thelongitudinal compressive force may vary from 20 N to 1000 N, or evenfrom 300 N to 1000 N. In other embodiments, the user may wish to measurethe stress inside the article, with a polarimeter, under conditions asclose to the regular use of said article as possible. In such a case,the longitudinal compressive force may vary from above 0 to 20 N inorder not to interfere with the measures of the stress inside thearticle with the polarimeter.

In an embodiment not shown, the proximal and distal holders (100, 200)may be in a fixed position with respect to each other, so that thearticle to be measured is maintained in a vertical position or in aninclined position, in other words, so that the longitudinal axis B isvertical or inclined.

With reference to FIG. 4, the supporting device 1 of FIGS. 1 and 3 isshown with the syringe body 2 of FIG. 2 a mounted thereon. Thereferences designating the same elements as in FIGS. 1, 2 a and 3 havebeen maintained. The syringe body 2 of FIG. 2 a is further provided witha needle 8 fixed at the conic distal tip 5 of the barrel 3.

As appears on FIG. 4, the proximal end 3 a of the barrel 3 of thesyringe body 2 is engaged on the distal conic part 15 of the port 14,and the distal end 3 b of the barrel 3 of the syringe body 2, in otherwords the conic distal tip 5, is engaged in the proximal portion 26 a ofthe central channel 26 of the head 23. As appears from the figure, theshape of the distal conic part 15 of the port 14 is adapted to receivesyringes having open proximal ends with a wide range of diameters. Theneedle 8 is received within the central hole 27 of the shaft 21, alignedon the central channel 26. Moreover, the helical spring 29 being in astressed state, it contributes to the longitudinal compressive forceapplied on the syringe body 2 along its longitudinal axis A and in thedirection of the center of said syringe body, thereby allowing theproximal end 3 a and the distal end 3 b to be engaged respectively withsaid port 14 and said receiving part 24 with friction. This longitudinalcompressive force, while being above 0 Newton, is neverthelesspreferably less than 1000 N, and more preferably less than 20 N in ordernot to interfere with the measures of the stress inside the article witha polarimeter as described below.

As a consequence, when the shaft 11 of the proximal holder 10 is rotatedaround the longitudinal axis B, for example manually by a user operatingthe handle 12, the syringe body 2 and the barrel 3 are caused to alsorotate around the longitudinal axis B.

Moreover, as appears clearly on FIG. 4, the structure and arrangement ofthe supporting device 1 of the kit of the invention allows the syringebody 2, and in particular the barrel 3, to be maintained in a determinedposition, and to be rotated in said position, by means of its proximaland distal ends (3 a, 3 b) only being in contact with the supportingdevice 1. Thanks to the supporting device 1 of the kit of the invention,there is no need of any intermediate part or element having to beoperated in the vicinity of the tubular barrel 3. As a consequence, whenthe article, for example the syringe body 2, is analyzed with apolarimeter, the light coming from the polarimeter, for example alongthe direction materialized by the arrow R on FIG. 4 or from any otherdirection around the article or syringe body 2, does not encounterundesired obstacle before reaching the barrel 3. This allows obtainingreliable measures of the stress present inside the barrel 3. Actually,the light sent by the polarimeter goes through a first wall of thebarrel 3 and through the diametrically opposed wall of said barrel 3.The polarimeter therefore measures the addition of the stress presentinside the two walls of the barrel 3 traversed by the light: it measuresthe stress present inside the barrel 3.

In an embodiment not shown, the syringe body 2 of FIG. 4 is replaced byone of the ampoule (6; 7) of FIGS. 2 b and 2 c. In such embodiments, theport of the supporting device of the kit of the invention is providedwith a ring, the distal face of which is provided with a central recess.When the ampoule 6 of FIG. 2 b is to be mounted on the supporting deviceof the kit of the invention, the central recess is similar to thecentral channel of the receiving part 24 of FIGS. 1 and 3 in order toreceive the conic proximal end 6 a of the ampoule 6. Alternatively, whenthe ampoule 7 of FIG. 2 c is to be mounted on the supporting device ofthe kit of the invention, the central recess of the ring of the port hasinner dimensions adapted to receive the flat bottom 7 a of the proximalend 7 a of the ampoule 7.

In an embodiment not shown, the vial 8 of FIG. 2 d is mounted on thesupporting device of the kit of the invention: in such a case, each ofthe port and the receiving part comprises a ring provided with a centralrecess intended to receive the flat bottom 8 a, respectively the collar8 b.

Alternatively, a cartridge may be mounted and put under longitudinalcompression on the supporting device of the kit of the invention, so asto be further assessed.

The method of the invention for putting under compression, measuring thestress inside, and optionally further assessing the quality and/or thestrength of, an article having a longitudinal axis A, a proximal end anda distal end, said article being made of a transparent material such asglass, polyolefin or polycarbonate can therefore be implemented asfollows: the article to be measured is mounted on the supporting device1 as described above for FIG. 4, ie by engaging said proximal end ofsaid article into said port and said distal end of said article intosaid receiving part, and applying on said article a longitudinalcompressive force of more than 0 Newton. The value of the longitudinalcompressive force may be adjusted as described above. In case a measureof the stress inside the article under no specific stressing conditionsis to be performed, the longitudinal compressive force is generally lessthan 20 N and a polarimeter is used. Alternatively, in case a measure ofthe stress inside the article under specific stressing conditions is tobe performed, the longitudinal compressive force ranges generally from20 N to 1000 N, or even from 300 N to 1000 N and a polarimeter is used.A first measure may be completed using the polarimeter, the light ofwhich is directed towards the part of the article to be assessed, inparticular towards the tubular barrel 3 in case of a syringe body 2 asdescribed in FIG. 2 a. Alternatively or in combination, the stressinside the distal tip may also be measured.

Any known polarimeter is suitable for the method of the invention. As anexample, one can cite the polarimeter “STRAMO” from the company SGCC.

For example, the following steps may be completed: After a first measureis completed, the article, the syringe body 2 of FIG. 4, is rotated forexample by an angle of 30°. A second measure is completed. This step isrepeated 5 times. The method of the invention allows performing a seriesof at least six measures for example, all around the circumference ofthe barrel 3 of the syringe 2, thereby enabling to obtain reliableaverage values. The method of the invention is therefore reproducibleand can be used in an industrial process in order to determine whetherthe syringe bodies of a batch just manufactured are likely to break inthe future or not.

For example, it is possible to determine a maximum limit value of stressabove which it is decided that the risk that the syringe body breakswhen subsequently handled for example during a fill in operation is toohigh, therefore justifying that said syringe body be disposed of. It isthen possible to implement the method of the invention at an industrialprocess level in order to maintain only the syringe bodies satisfying toa stress value, measured according to the method of the invention, belowsaid maximum limit value.

In an embodiment of the invention not shown, the supporting device 1 andthe syringe body 2 mounted thereon as shown on FIG. 4 are immersedwithin a liquid having a refractive index substantially identical tothat of the transparent material forming the barrel 3, for exampleglass. Such an embodiment allows measuring the stress within thethickness of the wall of the barrel, with a polarimeter, and not onlyinside the barrel 3, as explained above.

The kit and the method of the invention therefore allow improving themanufacturing process of articles made of a brittle transparent materialsuch as syringe bodies and ampoules in the medical field.

1. A kit, comprising a supporting device for maintaining underlongitudinal compression an article made of a transparent materialhaving a longitudinal axis A, a proximal end and a distal end, saidsupporting device comprising: a proximal holder including a portintended to receive the proximal end of said article, and a distalholder including a receiving part intended to receive the distal end ofsaid article, wherein said port and said receiving part are beingaligned on the same longitudinal axis B, and compression means forputting said article under longitudinal compression directed towards acenter of said article, when said article is mounted on said supportingdevice with its longitudinal axis A aligned on said longitudinal axis B,said kit further comprising a polarimeter for measuring the stress inthe article, when said article is mounted on said supporting device. 2.The kit according to claim 1, wherein at least one of said port andreceiving part is rotatable around said longitudinal axis B.
 3. The kitaccording to claim 1, wherein said port is fixed in translation withrespect to said proximal holder along the direction of said longitudinalaxis B.
 4. The kit according to claim 1, wherein said receiving part ismovable in translation with respect to said distal holder along thedirection of said longitudinal axis B.
 5. The kit according to claim 1,wherein said compression means comprises biasing means for directing oneof said port and said receiving part toward the other one of said portand receiving part.
 6. The kit according to claim 1, wherein said portis provided with a distal conic part distally tapered.
 7. The kitaccording to claim 1, wherein said receiving part comprises a ringtraversed by a central channel aligned on said longitudinal axis B. 8.The kit according to claim 1, comprising said article.
 9. The kitaccording to claim 8, wherein said article has a substantially tubularshape.
 10. The kit according to claim 8, wherein said transparentmaterial is selected from glass, polyolefin, polycarbonate andcombinations thereof.
 11. The kit according to claim 8, wherein saidtransparent material is glass.
 12. The kit according to claim 8, whereinsaid article is a syringe body having a tubular barrel provided with asubstantially conic distal tip, said supporting device comprises a portprovided with a distal conic part distally tapered and a receiving partcomprising a ring traversed by a central channel aligned on saidlongitudinal axis B, said distal conic part being engaged by friction ina proximal end of said tubular barrel and said conic distal tip beingengaged in said central channel when said syringe body is mounted onsaid supporting device.
 13. The kit according to claim 8, wherein saidarticle is mounted on said supporting device, and said transparentmaterial has a refraction index R1, said supporting device and articleare immersed within a liquid having a refraction index substantiallyidentical to R1.
 14. A method for measuring the stress inside an articlehaving a longitudinal axis A, a proximal end and a distal end and madeof a transparent material, comprising: providing a supporting device formaintaining under longitudinal compression an article made of atransparent material having a longitudinal axis A, a proximal end and adistal end, comprising: a proximal holder including a port intended toreceive the proximal end of said article, and a distal holder includinga receiving part intended to receive the distal end of said article,wherein said port and said receiving part are aligned on the samelongitudinal axis B, and compression means for putting said articleunder longitudinal compression directed towards a center of saidarticle, when said article is mounted on said supporting device with itslongitudinal axis A aligned on said longitudinal axis B, and providing apolarimeter for measuring the stress in the article, when said articleis mounted on said supporting device; mounting said article on thesupporting device by engaging said proximal end of said article intosaid port and said distal end of said article into said receiving part,and applying on said article a longitudinal compressive force of morethan 0 Newton, and measuring the stress inside the article with thepolarimeter by directing the light of said polarimeter towards saidarticle.
 15. The method according to claim 14, wherein said longitudinalcompressive force ranges from above 0 to 1000 N.
 16. The methodaccording to claim 14, wherein said longitudinal compressive forceranges from above 0 to 20 N.
 17. The method according to claim 14,wherein said article having a substantially tubular shape, such as abarrel, said article is rotated around the longitudinal axis B of anangle selected in the range of 0-360°.
 18. The kit according to theclaim 8, wherein the article is selected from the group of a syringebody, a cartridge, a vial and an ampoule.
 19. The method according toclaim 14, wherein said longitudinal compressive force ranges from above20 to 1000 N.
 20. The method according to claim 14, wherein saidlongitudinal compressive force ranges from above 300 N to 1000 N.